investigation of neural stem cells in ischemic stroke

Conditions: Ischemic Stroke; Chronic Stroke; Hemiparesis; Arm Paralysis

Summary: a study of stereotactic, intracerebral injection of ctx0e03 neural stem cells into patients with moderate to moderately severe disability as a result of an ischemic stroke.

this is a randomized, placebo-controlled, multi-center study. patients with persistent disability 6-24 months following an ischemic stroke will be enrolled following confirmation of eligibility. patients will be randomized 2:1 to undergo a stereotactic surgery and receive a single administration of ctx0e03 drug product by intracerebral implantation or undergo sham surgery only (placebo). patients will be followed for 12 months after surgery with follow-up assessments occurring at various time points over the 12 months. all eligible patients will be assigned a standardized physical therapy (pt) program. patients will complete their daily pt exercises at home for 12 weeks after their surgery.

Eligibility criteria:
inclusion criteria: * ischemic stroke that includes the supratentorial region as confirmed by ct or mri, occurring within 6 to 24 months of the time that surgical intervention will be performed (qualifying stroke event) * modified rankin score of 3 or 4 due to the qualifying stroke event * some residual upper limb movement * sufficient cognitive and language abilities to comprehend verbal commands and to carry out the study assessments * no medical conditions that would preclude neurosurgery with appropriate preparation and management. * ability to attend study visits and complete all study assessments including ability to provide informed consent exclusion criteria: * modified rankin score of \>1 prior to the qualifying stroke event * stroke due to hemorrhage or stroke known or suspected of being caused by, or related to, connective tissue disorder, congenital disorder of the cerebral vessels or a disorder of thrombosis; patients with atrial fibrillation as a suspected cause of stroke are not excluded * neurosurgical pathway obstructed by vascular malformation or cavity * history of neurological or other disease resulting in significant functional impairment (e.g. parkinson's disease, motor neuron disease, moderate dementia, arthritis, contractures or fixed anatomical abnormality) * inability to stop or transition off valproic acid or other demethylating agents or histone deacetylases (hdac) inhibitors for 1 week before and 4 weeks after surgery * use of selective serotonin reuptake inhibitors (ssri), unless the subject is on a stable dose that has been started at least 2-months before screening (v1) * use of antispasticity medications (excluding oral antispasticity medications if they have been taken regularly for at least one month prior to surgery)the use of botox® or similar is allowed if the last dose was ≥3 months prior to screening; however, its use will be prohibited until following the 12 month visit * inability to discontinue anticoagulation therapy for a required interval * history of malignant disease within the last 5 years, or any history of primary or secondary brain malignant disease * patients who have previously participated in a cell-based therapy study at any time or in any other study involving an investigational product or rehabilitation study within the last 30 days * patients with clinically significant lab values, including positive class i human leukocyte antigen (hla) antibodies specific for ctx0e03 * planned initiation of any new pt regimen within 6-months of surgery

Keywords: efficacy neural stem cells intracerebral cerebral infarction cerebrovascular disorders brain diseases stereotactic surgery